Cardiac Echocardiography AssessmentPhase 4NCT01253889
Sweetheart Study: Oral Glucose for Reducing Stress During Echocardiographic Assessment in Infants in the NICU
A Phase 4 study testing Glucose 25% oral solution and Oral water in people with Cardiac Echocardiography Assessment, run by Children's & Women's Health Centre of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to compare the effect of a 25% glucose solution given via a soother with or without facilitated tucking with a similarly administered water placebo (control condition) on infant stress responses during and immediately after a neonatologist performed ECHO (np-ECHO). Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Cardiac Echocardiography Assessment
- What is being tested?
- Glucose 25% oral solution and Oral water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2010to Jun 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born between 26-42 weeks of gestational age admitted to the Neonatal Intensive Care Unit who require a np-ECHO for clinical purposes as indicated by the medical team.
Who cannot join
- Infants who have congenital anomalies, or a lethal condition in whom intensive care is not indicated;
- Infants below the gestational age of 26 completed weeks;
- Infants who have received analgesics or sedatives within 72 hours of the assessment;
- History of maternal abuse of controlled drugs and substances.
- Infants who are too unstable to receive oral medications or be exposed to a np-ECHO or who already have had an ECHO performed by a Pediatric Cardiologist within 4 hours.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Children's & Women's Health Centre of BC
Vancouver, British Columbia
About this study
Official title: Glucose 25% and Facilitated Tucking for Reducing Procedural Stress During Neonatologist-performed Cardiac Echocardiography in Infants in the NICU
The purpose of this study is to compare the effect of a 25% glucose solution given via a soother with or without facilitated tucking with a similarly administered water placebo (control condition) on infant stress responses during and immediately after a neonatologist performed ECHO (np-ECHO).
Read the detailed description
One hundred and four infants were randomized to one of four groups during a single np-ECHO examination, at the discretion of the medical team. Randomization to soother and water (Control) with and without facilitated tucking or to soother and 25% glucose (Intervention) with or without facilitated tucking will be determined by generating randomly permuted sequential blocks of four and six allocation numbers.
- Conditions
- Cardiac Echocardiography Assessment
- Being tested
- Glucose 25% oral solution, Oral water
- Keywords
- Functional echocardiography, oral glucose, neonatal stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose 25% oral solutionDrug
Also called glucose
0.5ml of 25% glucose (26-31 weeks gestational age group) or 1.0 ml of 25% glucose (32-42 weeks gestational age group). This application can be repeated if necessary to a maximum of four times, adding up to max 2ml of 25% glucose in the 26-31 weeks gestational age group or 4ml of 25% glucose in the 32-42 weeks gestational age group.
Oral waterOther
0.5ml of oral water (26-31 weeks gestational age group) or 1.0 ml of oral water (32-42 weeks gestational age group). This application can be repeated if necessary to a maximum of four times, adding up to max 2ml of oral water in the 26-31 weeks gestational age group or 4ml of oral water in the 32-42 weeks gestational age group.
| Study group | Role | What they receive |
|---|---|---|
| Oral Glucose with soother | Active comparator | Oral Glucose 25% first given two minutes before the first contact by the physician performing the np-ECHO. A soother will be held in the infant's mouth to ensure that continuous contact is maintained throughout the testing period. Repeat application of solution as per study protocol. No other non-pharmaceutical interventions for stress reduction will be applied. During each np-ECHO, infants have additional handling only if it is required to maintain physiological stability. Receives: Drug: Glucose 25% oral solution |
| Oral water with soother | Placebo comparator | Oral water first given two minutes before the first contact by the physician performing the np-ECHO. A soother will be held in the infant's mouth to ensure that continuous contact is maintained throughout the testing period. Repeat application of solution as per study protocol. No other non-pharmaceutical interventions for stress reduction will be applied. During each np-ECHO, infants have additional handling only if it is required to maintain physiological stability. Receives: Other: Oral water |
| Oral glucose with soother and tucking | Active comparator | For the infants randomized to receive facilitated tucking throughout the procedure, the bedside nurse will provide gentle, firm containment of the extremities. The facilitated tucking will commence immediately after the baseline BIIP score is taken, but before the glucose/water is administered. Receives: Drug: Glucose 25% oral solution |
| Oral water with soother and tucking | Placebo comparator | For the infants randomized to receive facilitated tucking throughout the procedure, the bedside nurse will provide gentle, firm containment of the extremities. The facilitated tucking will commence immediately after the baseline BIIP score is taken, but before the glucose/water is administered. Receives: Other: Oral water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Behavioral Indicators of Infant Pain (BIIP) Score
The Behavioral Indicators of Infant Pain (BIIP) is a reliable and valid scale for assessing acute procedural pain in preterm infants.
Measured: study day 1
Secondary outcomes (5)
Time to complete a standard ECHO
Defined when ultrasound images have been acquired for all four cardiac views
Measured: study day 1
Total number of times solutions are given to infants (max 4 times)
Measured: study day 1
Quality of np-ECHO images assessed by blinded cardiologists
Measured: study day 1
Mean heart rate from baseline to end of ECHO
Measured: study day 1
Cardiorespiratory instability
Measured: study day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Echocardiography AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's & Women's Health Centre of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liisa Holsti, Children's & Women's Health Centre of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253889
- Sponsor's protocol ID
- H10-02069
- Status last verified
- Feb 2017
- First submitted
- 2 Dec 2010
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lavoie PM, Stritzke A, Ting J, Jabr M, Jain A, Kwan E, Chakkarapani E, Brooks P, Brant R, McNamara PJ, Holsti L. A Randomized Controlled Trial of the Use of Oral Glucose with or without Gentle Facilitated Tucking of Infants during Neonatal Echocardiography. PLoS One. 2015 Oct 23;10(10):e0141015. doi: 10.1371/journal.pone.0141015. eCollection 2015.
PubMed 26496361
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose 25% and Facilitated Tucking for Reducing Procedural Stress During Neonatologist-performed Cardiac Echocardiography in Infants in the NICU
- ClinicalTrials.gov ID
- NCT01253889
- Acronym / sponsor ID
- H10-02069
- Conditions
- Cardiac Echocardiography Assessment
- Keywords
- Functional echocardiography, oral glucose, neonatal stress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Children's & Women's Health Centre of British ColumbiaUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 6 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effect of a 25% glucose solution given via a soother with or without facilitated tucking with a similarly administered water placebo (control condition) on infant stress responses during and immediately after a neonatologist performed ECHO (np-ECHO).
Detailed description
One hundred and four infants were randomized to one of four groups during a single np-ECHO examination, at the discretion of the medical team. Randomization to soother and water (Control) with and without facilitated tucking or to soother and 25% glucose (Intervention) with or without facilitated tucking will be determined by generating randomly permuted sequential blocks of four and six allocation numbers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oral Glucose with soother | Active comparator | Drug: Glucose 25% oral solutionOral Glucose 25% first given two minutes before the first contact by the physician performing the np-ECHO. A soother will be held in the infant's mouth to ensure that continuous contact is maintained throughout the testing period. Repeat application of solution as per study protocol. No other non-pharmaceutical interventions for stress reduction will be applied. During each np-ECHO, infants have additional handling only if it is required to maintain physiological stability. |
| Oral water with soother | Placebo comparator | Other: Oral waterOral water first given two minutes before the first contact by the physician performing the np-ECHO. A soother will be held in the infant's mouth to ensure that continuous contact is maintained throughout the testing period. Repeat application of solution as per study protocol. No other non-pharmaceutical interventions for stress reduction will be applied. During each np-ECHO, infants have additional handling only if it is required to maintain physiological stability. |
| Oral glucose with soother and tucking | Active comparator | Drug: Glucose 25% oral solutionFor the infants randomized to receive facilitated tucking throughout the procedure, the bedside nurse will provide gentle, firm containment of the extremities. The facilitated tucking will commence immediately after the baseline BIIP score is taken, but before the glucose/water is administered. |
| Oral water with soother and tucking | Placebo comparator | Other: Oral waterFor the infants randomized to receive facilitated tucking throughout the procedure, the bedside nurse will provide gentle, firm containment of the extremities. The facilitated tucking will commence immediately after the baseline BIIP score is taken, but before the glucose/water is administered. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants born between 26-42 weeks of gestational age admitted to the Neonatal Intensive Care Unit who require a np-ECHO for clinical purposes as indicated by the medical team.
Key exclusion criteria (5 listed)
- Infants who have congenital anomalies, or a lethal condition in whom intensive care is not indicated;
- Infants below the gestational age of 26 completed weeks;
- Infants who have received analgesics or sedatives within 72 hours of the assessment;
- History of maternal abuse of controlled drugs and substances.
- Infants who are too unstable to receive oral medications or be exposed to a np-ECHO or who already have had an ECHO performed by a Pediatric Cardiologist within 4 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose 25% oral solutionAlso: glucose0.5ml of 25% glucose (26-31 weeks gestational age group) or 1.0 ml of 25% glucose (32-42 weeks gestational age group). This application can be repeated if necessary to a maximum of four times, adding up to max 2ml of 25% glucose in the 26-31 weeks gestational age group or 4ml of 25% glucose in the 32-42 weeks gestational age group. | Drug | Oral Glucose with soother, Oral glucose with soother and tucking |
| Oral water0.5ml of oral water (26-31 weeks gestational age group) or 1.0 ml of oral water (32-42 weeks gestational age group). This application can be repeated if necessary to a maximum of four times, adding up to max 2ml of oral water in the 26-31 weeks gestational age group or 4ml of oral water in the 32-42 weeks gestational age group. | Other | Oral water with soother, Oral water with soother and tucking |
Primary outcome
Change in Behavioral Indicators of Infant Pain (BIIP) Score
Time frame: study day 1
The Behavioral Indicators of Infant Pain (BIIP) is a reliable and valid scale for assessing acute procedural pain in preterm infants.
5 secondary outcomes
Time to complete a standard ECHO
Time frame: study day 1
Total number of times solutions are given to infants (max 4 times)
Time frame: study day 1
Quality of np-ECHO images assessed by blinded cardiologists
Time frame: study day 1
Mean heart rate from baseline to end of ECHO
Time frame: study day 1
Cardiorespiratory instability
Time frame: study day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Derived from this study: PubMed 26496361Lavoie PM, Stritzke A, Ting J, Jabr M, Jain A, Kwan E, Chakkarapani E, Brooks P, Brant R, McNamara PJ, Holsti L. A Randomized Controlled Trial of the Use of Oral Glucose with or without Gentle Facilitated Tucking of Infants during Neonatal Echocardiography. PLoS One. 2015 Oct 23;10(10):e0141015. doi: 10.1371/journal.pone.0141015. eCollection 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glucose 25% oral solution and Oral water in people with Cardiac Echocardiography Assessment, run by Children's & Women's Health Centre of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Behavioral Indicators of Infant Pain (BIIP) Score (time frame: study day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01253889, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.